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Pfizer, Serum Institute and Bharat Biotech apply for EUA in India: Here’s what might happen next

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India, Dec. 8 — Hopes for an early vaccine for the coronavirus disease (Covid-19) in India have been rekindled after three firms, within days of each other, applied for emergency use authorisation (EUA) of their respective vaccine candidates in the country. While America’s Pfizer Inc was the first to apply on December 4, Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech International Limited applied on December 6 and 7 respectively.

Click here for full Covid-19 coverage

While SII will manufacture in India the Oxford University-AstraZeneca vaccine candidate, Covishield, Bharat Biotech’s candidate, Covaxin, is the country’s first, and thus far only, indigenously developed vaccine candidate. According to reports, the EUA applications of all three companies will be reviewed on Wednesday.

Here’s what is likely to happen next:

1. The US Food and Drug Administration (FDA) describes EUA as “mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current Covid-19 pandemic.” For approval for full-time use, a company needs to submit, among other information, data on the vaccine candidate’s efficacy.

Also Read | Emergency use authorisation for Covid-19 vaccines explained

2. In India, the power to grant EUA lies with the Central Drugs Standard Control Organisation (CDSCO). However, there are no provisions for EUA under India’s drug regulations. In such a scenario, processes to obtain EUA here are not clearly defined. However, CDSCO had granted permission for the use of drugs like remdesivir and favipiravir in June, and itolizumab in July.

3. Since there are no fixed rules for granting EUA in India, the minimum efficacy that a candidate needs to have to be granted permission for use in emergency cases is not yet known. In FDA’s case, the agency says it would consider a EUA application only if the vaccine candidate has shown at least 50% efficacy in phase 3 trials. Additionally, the data should have been generated from more than 3,000 participants.

4. In terms of how long it might take for a vaccine candidate to be granted EUA in India, Dr VK Paul, NITI Aayog member, told NDTV it might take 90 days for an EUA application to be reviewed and permission to be granted. The Drugs Controller General of India (DCGI) is the department within CDSCO which grants such approvals.

5. Globally, Pfizer has filed for EUA in the United States and the application is likely to be reviewed this week. The United Kingdom on Tuesday initiated the use of Pfizer’s vaccine candidate in emergency cases. Bahrain, too, has granted EUA for the US firm’s vaccine.

For any query with respect to this article or any other content requirement, please contact Editor at [email protected] Digital streams Ltd

‘Start Up’ cast say goodbye to drama

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South Korean TV drama, tvN’s Start-Up has aired its final episode on December 6 and the main cast shared their closing remarks about the show.

The show takes place in a fictional South Korean version of Silicon Valley and it revolves around young people striving to achieve success in the world of startup companies. Suzy plays Seo Dal Mi, an adventurer who aspires to become Korea’s Steve Jobs while Nam Joo Hyuk plays the role of Samsan Tech founder Nam Do San.

Suzy shared, “I feel a mix of both happiness and sadness. During the eight months I spent in my role as Seo Dal Mi, I felt very comforted and also very happy, so I’m sad that filming has come to an end.” She continued, “Also, this drama turned out so well thanks to all of the amazing staff who worked hard for eight months. It was an honour to be a part of this production. I hope you will support ‘Start-Up’ until the end.”

Next, Nam Joo Hyuk commented, “All of the staff and actors worked so hard the past eight months. Eight months felt like a long time, but it feels so short now that it’s over. I’ve learned a lot while acting as Nam Do San and watching him grow and mature. It feels like I grew together with him. Thank you for showing so much love for ‘Start-Up.’”

Nam Joo Hyuk stars as Nam Do San in Start-Up. Picture: Instagram

Kim Seon Ho, who took on the role of managing director Han Ji Pyeong, said, “The past eight enjoyable and happy months felt so long and so short at the same time. The time I spent sharing my worries together with others will become very meaningful to me. I want to give my thanks to the director, the writer, the actors, all of the staff, and especially to all of the viewers who gave their love to the drama. We were able to create a good production because we were together. Please keep ‘Start-Up’ in your memory. Thank you once again.”

Kang Han Na, who played Seo Dal Mi’s sister Won In Jae, shared, “During the past eight months, I immersed myself in filming as the character Won In Jae while thinking of all the youth who are taking on their own challenges. I hope that the viewers were able to gain positive energy from not only Won In Jae’s story, but from the stories of the other characters as well. Please enjoy the final episode. Thank you so much.”

MB: Johor poised to be regional hub for drones, robotics with dedicated zone in Iskandar Malaysia

ISKANDAR PUTERI, Dec. 8 — Johor may become a major player in the regional drone and robotics industry with a dedicated zone that could attract investments worth RM350 million and create over 1,000 job opportunities by 2025, said Mentri Besar Datuk Hasni Mohammad.

He said the Drone and Robotic Zone (DRZ) Iskandar has great potential and will make the state as a leader in the region’s drone and robotics industry.

He said the initiative was also in line with the state government’s efforts to set up a Digital Hub in the region as announced in the Johor Budget 2021.

“Johor needs an integrated ecosystem to enable the state to further develop the digital economy sector, especially for the Southeast Asian region.

“The establishment of this zone is also expected to attract investment worth more than RM350 million, besides creating more than 1,000 new job opportunities in the drones and robotics industry,” said Hasni in a virtual address during the event’s launch at DRZ Iskandar in Bandar Medini here today.

Witnessing the launch of the event was Science, Technology and Innovation Minister Khairy Jamaluddin.

DRZ Iskandar is a collaboration between Iskandar Investment Berhad (IIB), together with global logistics company DHL and Malaysian Global Innovation and Creativity Centre (MaGIC).

IIB president and chief operating officer Datuk Khairil Anwar Ahmad said exploration in drone and robotics technology could be utilised in various economic sectors.

“Among the sectors involved are security, agriculture, logistics and various branches of the services sector.

“In addition, a better understanding of this technology will also enable us to explore the use of drones and robotics in various other sectors in the future,” he said.

Khairil Anwar pointed out that the latest situation involving the Covid-19 pandemic has seen digital technology play an important role, especially in driving the country’s economic sector.

“As a country, we need to keep pace with the latest technology by making Singapore an example, where digital technology is integrated in their daily affairs,” he said.

For any query with respect to this article or any other content requirement, please contact Editor at [email protected] 2017 Malay Mail Online

Heng Swee Keat takes #toast2Uchallenge, nominates East Coast MPs to do the same

Singapore—Deputy Prime Minister Heng Swee Keat not only honoured the country’s frontline workers with a toast but also challenged his fellow East Coast GRC Members of Parliament to do the same and upload videos of their own toasts.

DPM Heng, who is also the country’s Finance Minister, took to Facebook on Monday (Dec 7) and uploaded a video of himself with a beverage in hand. In the video he said, “Thank you to all our frontline workers, who have been working hard to keep Singapore, and all our people in Singapore, safe. Cheers!”

In honor of frontliners, DPM Heng wrote, “Your selflessness and commitment have shone through as you bravely care for those affected and give in your all to contain the spread of the virus. You are an inspiration to all of us! My sincere thanks to each and every one of you.”

The video shows the DPM passing the toast challenge on, as he takes the beverage from one side, and then passes it to the next, (although he doesn’t actually take a sip). He tagged fellow East Coast GRC MPs Dr Maliki Osman, Tan Kiat How,  Jessica Tan Soon Neo, and Cheryl Chan, as a challenge for them to do the same.

He nominated the East Coast team for the challenge “as we stand in solidarity to show our appreciation to workers,” but also encouraged others  to join this meaningful initiative by uploading your own video post.”

DPM Heng added that each #toast2U #toast2Uchallenge hashtag means a S$2 pledge from NTUC Income to the NTUC- U Care Fund. The fund “helps low-income members and their families through various assistance programmes to defray their cost of living and children’s school expenses, as well as members whose livelihood had been affected by COVID-19,” wrote DPM Heng.

Those who accept the challenge need to upload a video of themselves “‘receiving’ the drink from the person who nominated’ them, and then “give a toast accompanied by a note of appreciation in the post,” before “passing” on the drink to two other people they nominate.

“Tag U Heart (@UHeartsg) for us to keep track of the donations, and remember to make your post public!,” added the Deputy Prime Minister.  “This is an initiative by nEbO x Young NTUC U Heart 2020, supported by NTUC Income.”

Among DPM Heng’s fellow East Coast GRC MPs, only Mr Tan Kiat How has so far taken up the challenge.

On the same day he was nominated, Mr Tan uploaded a toast of his own, writing, “Here’s a toast to thank all our frontline and essential workers who have been working tirelessly in our battle against COVID-19, and keeping Singapore and Singaporeans safe!”

FB screengrab: Tan Kiat How

He followed DPM Heng’s example of taking the beverage from one side and passing it to the next. —/TISG

Read also: PM-designate Heng Swee Keat also told P6 pupils that their future does not depend on one exam

PM-designate Heng Swee Keat also told P6 pupils that their future does not depend on one exam

Son of JB Jeyaretnam appointed to Supreme Court bench

Singapore—Mr Philip Jeyaretnam has been appointed by President Halimah Yacob as a Judicial Commissioner of the Supreme Court of Singapore, announced the Prime Minister’s Office on Monday (Dec 7).

His term starts on Jan 4, 2021, and will be for a period of one year.

Mr Jeyaretnam is the son of one of Singapore’s most notable political figures in recent history, Mr Joshua Benjamin, also known as JB Jeyaretnam. He is also the brother of Mr Kenneth Jeyaretnam, the Secretary-General of the Reform Party, which Mr JB Jeyaretnam founded.

The new appointee studied Law at Cambridge, graduating with First Class Honours in 1986. He worked with the law firms Robert Wang & Woo, Chor Pee and Partners, and Helen Yeo & Partners, where he was a Partner.

The firm later merged with Rodyk & Davidson in 2002, and later Mr Jeyaretnam became Managing Partner of Rodyk & Davidson LLP.

In 2016, he led the firm’s merger with Dentons, which then became Dentons Rodyk & Davidson LLP.

The PMO’s statement reads, “Concurrently with his active practice in arbitration and litigation, he has been part of Dentons global management since then, holding the position of ASEAN CEO and Global Vice Chair of Dentons.”

Moreover, in 2003, when he was 38 years old, he was conferred the title of Senior Counsel, one of the youngest lawyers to have been thus appointed.

He was also the President of the Law Society from 2004 to 2007.

Of Mr Jeyaretnam’s areas of expertise, the statement from the PMO says that his “practice in arbitration and litigation has focused on commercial law and construction law. He is widely recognised as a leading expert in arbitration, construction law and litigation in all major legal publications.”

The new appointee is also a much-lauded novelist. First Loves, his short story anthology, was a bestseller when it was published in 1987, causing The Business Times to call him the country’s “home-grown Maugham.” The anthology, as well as his first novel, Raffles Place Ragtime, published the following year, were nominated for the Commonwealth Writers Prize.

His next novel, Abraham’s Promise, was highly commended by the National Book Development Council of Singapore and was chosen by The Business Times in 2015 as of the Top 10 English Singapore books from 1965 to 2015.

In 1993, Mr Jeyaretnam’s literary efforts won him the ‘Young Artist of the Year’ award. Four years later he won the Montblanc-NUS Centre for the Arts Literary Award, and in 2003, the S.E.A. Write Award.

Additionally, from 2005 to 2013, Mr Jeyaretnam was an Adjunct Professor with the Department of Building at the National University of Singapore.

From the beginning of next year, with Mr Jeyaretnam’s appointment, Singapore’s Supreme Court will have 25 Judges in all, which includes the Chief Justice and four Judges of Appeal, as well as six Judicial Commissioners, four Senior Judges, and 17 International Judges.

The PMO also announced on Nov 28 the appointment of a third Deputy Attorney-General, as well as a new judicial commissioner and High Court Judge, also effective early next year. —/TISG

Read also: Singapore to get third Deputy AG, new High Court judge and new judicial commissioner

Singapore to get third Deputy AG, new High Court judge and new judicial commissioner

Hope is on the UK as it starts mass Covid vaccination programme

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by Phil HAZLEWOOD

Britain on Tuesday hailed a turning point in the fight against the coronavirus pandemic, as it begins the biggest vaccination programme in the country’s history with a new Covid-19 jab.

The first patients in line on what has been dubbed “V-Day” — the over-80s, care home workers and at-risk frontline health and social care staff — will roll up their sleeves for an initial dose from early morning.

They will then require a second jab in 21 days’ time.

Last week Britain became the first country to approve the Pfizer-BioNTech vaccine, raising hopes of a breakthrough in the pandemic, which has killed more than 1.5 million worldwide.

Britain has been one of the worst-affected countries in the world, with more than 61,000 deaths in the outbreak from 1.6 million cases.

Prime Minister Boris Johnson, who spent days in intensive care with Covid-19 earlier this year, called it a “huge step forward in the UK’s fight against coronavirus”.

UK Health Secretary Matt Hancock, who has offered to have the jab on live television to allay public fears, said the roll-out was a “key moment” that would protect the most vulnerable.

The head of the state-run National Health Service in England, Simon Stevens, said it was a “decisive turning point” against the “greatest health challenge” since the NHS was founded in 1948.

Regulatory approval for the vaccine was given last Wednesday, sparking a race against time to prepare scores of vaccination centres across the country.

The UK has ordered 40 million doses of the jab — enough to vaccinate 20 million people — with 800,000 in the first batch.

Up to four million doses are expected by the end of December.

Queen could lead way
The mass vaccination drive is a coordinated response by all four nations of the UK — England, Scotland, Wales and Northern Ireland — which normally set their own health policies.

The public has been largely favourable to the rapid approval of the vaccine, but ministers and health professionals are aware they still need to combat mistrust.

The independent Medicines and Healthcare products Regulatory Agency maintains that no corners were cut and its assessment and approval procedures met stringent international norms.

NHS England said thousands had already been given the jab during trials with no serious side effects.

Nevertheless, it has been reported Queen Elizabeth II, who at 94 is among those first in the line for the vaccination because of her age, could front a public awareness campaign urging compliance.

The government said it will hand out vaccine cards to remind people to get the booster after three weeks, but insisted it was not introducing immunity certificates.

– ‘Marginal impact’ in winter –
The chief medical officers of England, Scotland, Wales and Northern Ireland said the vaccine will as a result only have a “marginal impact” on hospital numbers over the winter months.

Johnson called for patience and urged the public to stick to strict social distancing guidelines to prevent a spike in cases, particular as rules are relaxed over Christmas.

Health officials have already run into a logistical headache about how to administer the vaccine to elderly or infirm care home residents.

The vaccine needs to be stored at -70 degrees Celsius (-94 Fahrenheit), leaving hospitals and other medical hubs as the only places able to deal with such ultra-low temperatures.

With the Pfizer-BioNTech drug made in Belgium, concerns have also been raised about potential disruption to supply when Britain leaves the European Union’s single market and customs union.

But the UK government said the military is on stand-by to air-lift the vaccine if there is any border disruption from January 1.

The bulk of Britain’s vaccine requirements are expected to be met by a jab developed by AstraZeneca and the University of Oxford, which is awaiting regulatory approval.

The government has ordered an initial 100 million doses of the drug, which is cheaper to manufacture, and easier to store and transport using conventional fridges.

© Agence France-Presse

Australia moves to rein in states’ deals with China

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Australia’s government can veto agreements that state authorities and universities ink with foreign countries under new legislation passed Tuesday, taking square aim at controversial deals with Beijing.

The new federal powers to scupper existing and future deals “where they adversely affect” the national interest comes as China and Australia are at loggerheads over trade and competing claims of influence in the Pacific.

“This legislation is necessary to appropriately manage and protect Australia’s foreign relations and the consistency of our nation’s foreign policy,” said foreign minister Marise Payne.

Under Australia’s constitution, the federal government is responsible for foreign affairs and defence. States typically deliver services such as health and education but in reality there is frequent overlap.

Future deals will now need government approval — in some cases before negotiations can even begin — and existing agreements can be declared invalid or terminated.

The new rules call into question Victoria state’s support for China’s “Belt and Road Initiative” — a vast network of projects that offers Beijing sizeable geopolitical and financial leverage.

Prime Minister Scott Morrison has been highly critical of a Victoria-China memorandum of understanding, and local media have quoted government officials as saying the deal is now “probably toast”.

Also in doubt is the presence of Chinese-government-backed Confucius Institutes at Australia’s public universities which critics say promotes the Communist Party’s self-serving version of Chinese culture and history.

The laws do not cover commercial deals and do not specifically name any single country.

But there is widespread unease in Australia at China’s growing influence and Canberra has banned state-linked telecoms giant Huawei from building Australia’s 5G network.

It has also tightened foreign investment laws for corporations and created a register of foreign-paid lobbyists, with the attorney general writing to universities and Confucius Institutes on the issue.

Tensions spiked in April when Australia infuriated China by calling for an independent probe into the origins of the coronavirus pandemic, which emerged in the Chinese city of Wuhan late last year.

© Agence France-Presse

Photo of Chiam See Tong and JBJ in parliament recirculates

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An old photo of opposition politicians Chiam See Tong and J. B. Jeyaretnam (also known as JBJ) made its way round social media on Sunday (Dec 6).

Sharing the photo in a Facebook group titled ‘Concerned citizens band together for a better Singapore’, the netizen wrote: “I was casually on my phone yesterday when I stumbled upon an article on 红蚂蚁, where I saw this photo of two former MPs we all must be so so so proud of and grateful for”.

They wrote that both Mr Chiam and JBJ each went through a few years of being the only opposition Member of Parliament at one point of time, “with literally the entire opposition camp of politics on their shoulders”.

The netizen added that without the two men, the odds for Hougang and the other victories might not have been what they were.

“Even after facing lawsuits, expulsion from parliament and bankruptcy, JBJ returned in GE1997, and almost made it in Cheng San GRC”, the netizen added.

They wrote: “Even after suffering from stroke, and reaching 76 years old, Chiam See Tong did not consider retirement just yet and EVEN went out of his way to move to Bishan-Toa Payoh GRC in GE2011 and attained a rather close and very much dignified loss”.

JBJ was the leader of the Workers’ Party from 1971 to 2001.

In 1981, he became the first opposition politician since Singapore’s independence in 1965 to win a seat in Parliament, when he defeated Pang Kim Hin of the governing People’s Action Party (PAP) in a by-election in Anson Single Member Constituency.

He left the Workers’ Party in 2001, was discharged from bankruptcy in 2007, and founded the Reform Party in June 2008.

He went to participate for the 1993 Singaporean presidential election but his application for the certificate of eligibility was rejected. He died of heart failure in September 2008, three months after founding the Reform Party, which is now led by his son Kenneth Jeyaretnam.

Mr Chiam was the second longest-serving opposition Member of Parliament (MP) after Low Thia Khiang, having represented the constituency of Potong Pasir in Parliament from 1984 to 2011.

Chiam was also formerly the longest-serving Opposition Leader in terms of total time served (1986–93, 1997–2006), as well as the opposition Member of Parliament (MP) (1984–2011) until the end of 2017, when former Workers’ Party (WP) then-secretary general Low Thia Khiang surpassed both of his records (Low served as an MP since 1991, and as an opposition leader from 2006 to 2018).

Chiam founded the Singapore Democratic Party (SDP) in 1980 and led the party up to 1996, when he left the party to join the Singapore People’s Party (SPP) prior to the 1997 general election. He subsequently spearheaded the formation of the Singapore Democratic Alliance (SDA), and was its chairman and de facto opposition leader from 2001 to 2011.

“We all can never be adequately thankful for them and all that they have done for Singapore” they added, concluding their post. /TISG

Lim Tean sums up Leong Sze Hian’s and Terry Xu’s trials against PM Lee

In two separate Facebook posts over the weekend (Dec 5,6), lawyer Lim Tean summed up the trials for both of his clients Terry Xu and Leong Sze Hian, who were embroiled in suits against Prime Minister Lee Hsien Loong.

On Saturday (Dec 5), the day after a week-long trial between The Online Citizen Editor Terry Xu and PM Lee, Mr Lim wrote: “The defamation proceedings Lee Hsien Loong launched against Terry Xu, and which came to trial this week, was very much about 38 Oxley Road, including the now famous demolition clause in Lee Kuan Yew’s various Wills”.

He added that voluminous evidence surrounding the controversy was tested in some detail in a public forum.

“I believe my cross-examination of Lee Hsien Loong revealed new aspects of the controversy which Singaporeans were hitherto unaware of”, Mr Lim wrote. He added that it was only when she spoke during the proceedings, that the public was able to hear for the first time from Mr Lee Kuan Yew’s lawyer, Kwa Kim Li.

“More could have been learnt from her if she had not claimed legal privilege to many of the questions which we had intended to pose to her in court”, Mr Lim wrote.

He added that he came into the picture very late on Mr Xu’s case, with only 6 weeks to go before trial.

The case involves a TOC article published in August last year, which referenced a Facebook post by Dr Lee, in which she claimed PM Lee had misled their late father, founding prime minister Lee Kuan Yew, into thinking 38 Oxley Road had been gazetted by the Government.

On Sept 1 last year (2019), PM Lee’s press secretary sent Mr Xu a letter asking him to take the article down and issue a “full and unconditional apology”. PM Lee initiated legal proceedings after Mr Xu refused to do so.

In another Facebook post on Sunday (Dec 6), Mr Lim shared a clip with a short statement made outside Court after the hearing where Final Oral Arguments were made in Lee Hsien Loong v Leong Sze Hian.

Mr Lim said: “We had very good oral arguments before Justice Aedit Abdullah this afternoon”.

He added that the judge will now deliberate before handing down a written argument. He added that he was very happy with the written arguments.

Mr Lim said that the judge understood that the law cannot be applied rigidly because “social media is a casual medium”.

PM Lee is suing Mr Leong for sharing an article from the Malaysian news site The Coverage.

The article had falsely linked PM Lee to the 1Malaysia Development Berhad (1MDB) corruption scandal in Malaysia. /TISG

Video of youth going at 120kmph in residential zone draws flak online

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Singapore — A video of youngsters going over 120kmph at a residential area is circulating on social media, much to the disappointment of the online community.

On Sunday (Dec 6), a video of the incident was first uploaded on sgroadaccidents’ Instagram page and was highlighted on a singaporeuncensored.com article. The video consists of several young people, tagged as ah bengs (an informal term used for a young man who wears fashionable or designer clothing and whose behaviour is considered brash), documenting themselves as they went beyond the speed limit on the road.

The young men were shouting as the driver presumably activated the VTEC (Variable Valve Timing & Lift Electronic Control) function, an automotive performance booster developed by Honda. The driver was then spotted steadily increasing the speed until it reached 121kmph before the video ended.

Photo: Instagram screengrab/sgroadaccidents

Facebook page ROADS.sg also shared the incident with the following caption, “We cannot verify the speed of the vehicle, but the speedometer registers 120 kph. Video speed could be edited to slow it down, but driving at those speeds in a residential zone of 70 kph is simply reckless and will attract Traffic Police’s attention.”

Members from the online community urged for authorities to put the group to task noting they were a danger to other road users. “They are just finding a loophole to escape their crimes,” commented Facebook user MinitJacky Wong. “In the first place, they already know ‘speeding is an offence and speeding kills’, and they are still doing it.”

Netizens also tagged the Singapore Police Force and Land Transport Authority in the Instagram post. “Please arrest these people. They were driving over the limit,” added Instagram user @kittesy. According to another netizen who identified the location, they were driving along Queensway road which has a speed limit of 50kmph.

Read related: Youths who go door-to-door selling keychains: Are they raising money for charity?

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